Bridging Clinical Operations And Supply Chain: Aligning Execution In High-Stakes Trials

By Casey Witt, Foxglove Clinical

As trials move toward more personalized and increasingly complex protocols, the stakes have never been higher for alignment between Clinical Operations and Supply Chain.

Advanced therapies, like gene and cell therapies, are not manufactured in bulk; they are produced for individual patients, and under highly specialized conditions. Each dose is tied to a specific patient and represents both a critical treatment opportunity and a significant investment. There is little room for error.

These dynamics place significant pressure on clinical trial teams, where even small disconnects can lead to forecasting inaccuracies, inventory imbalances, or delays in getting the right product to the right patient at the right time.

In this environment, strong communication is not a “nice to have”—it is the mechanism that protects both the product and the patient.

One of the most common, and preventable points of disconnect between Clinical Operations and Supply Chain teams is not lack of expertise, but lack of communication and integration.

Protocol amendments are a prime example. A seemingly straightforward change, like adjusting visit windows, adding a cohort, or modifying a dosing schedule can have significant downstream implications for supply forecasting, packaging, labeling, and distribution. Changes to visit schedules or dosing must be reflected in RTSM/IRT systems, which drive patient-level demand signals. As those signals shift, supply forecasts are recalculated, impacting inventory requirements across central, depot, and site levels, and may require relabeling or repackaging of existing kits. Too often, these changes are finalized before supply chain is engaged, forcing reactive adjustments instead of coordinated planning.

At the same time, clinical operations may be managing shifting enrollment dynamics, site challenges, and real-world constraints that are not fully visible to supply chain. Without consistent dialogue, both teams end up working from different versions of reality.

Site logistics further compound the issue. Storage limitations, pharmacy capabilities, staffing, and courier reliability all directly affect how and when supplies should be deployed. Without direct, ongoing communication with the teams closest to the sites, supply strategies risk being operationally impractical.

Collaboration From The Beginning

Effective collaboration starts with shared ownership and consistent communication, from start to finish.

How do we do this?

• Engage supply chain early during protocol development so feasibility and operational considerations are discussed up front, including how protocol design choices (visit schedules, dosing frequency, cohort structure) translate into demand signals, forecasting assumptions, and supply strategy (e.g., packaging approach, depot model, and distribution timelines).
• Maintain regular, forward-looking touchpoints that focus on what’s coming next — site activations, enrollment shifts, or protocol changes — while also reviewing supply metrics such as forecast vs. actual demand, depot and site inventory levels, resupply triggers, and upcoming packaging or labeling activities to ensure plans remain aligned with trial execution.
• Create clear pathways for escalation, so risks are surfaced early and addressed collaboratively, particularly when supply risks emerge, such as potential stockouts, depot imbalances, delays in packaging or labeling, or misalignment between IWRS configuration and actual site behavior.  
• Ensure both teams are part of key decisions, rather than informing one another after the fact, especially for changes that impact supply execution such as protocol amendments, enrollment strategy shifts, or site activation timelines, where downstream effects on forecasting, inventory positioning, labeling, and distribution need to be assessed in real time.

Don’t Forget About The Sites!

Clinical operations teams are closest to the sites. They understand how sites actually function — what they can handle, where they struggle, and how quickly they can execute. This insight is invaluable for supply chain but is often shared inconsistently or too late.

In more complex studies, particularly cell and gene therapy, this gap becomes more pronounced. Not all sites have the same infrastructure, experience, or readiness to manage highly specialized products.

Stronger collaboration in this area looks like:

• Ongoing feedback from site-facing teams, not just at start-up but throughout the study, including how sites are actually managing inventory, handling resupply shipments, and adapting to protocol requirements in real time, so supply plans can be adjusted based on actual site behavior rather than initial assumptions
• Open dialogue around site readiness, including staffing, storage, and training — not just activation status — so supply decisions around inventory levels, shipment frequency, and depot support are aligned with each site’s true operational capacity, particularly for specialized or temperature-sensitive products
• Alignment on realistic timelines, based on how sites are actually performing, not how they were expected to perform, ensuring supply forecasts, resupply timing, and distribution plans reflect real enrollment rates, dosing schedules, and site throughput

When supply chain has a clear picture of site reality, planning becomes more precise and far more reliable.

Conclusion

Clinical trials are inherently complex, but the friction between clinical operations and supply chain doesn’t have to be. Strong collaboration, grounded in consistent, transparent communication, can eliminate many of the challenges that delay studies and create unnecessary risk.

In advanced therapies, the stakes are even higher. These are not interchangeable doses — they are patient-specific, time-sensitive, and irreplaceable.

The goal is not just to deliver supplies on time; it is to ensure that every decision across functions is coordinated, intentional, and aligned with how trials are actually executed.

Because in the end, success is not defined by plans, it’s defined by how well teams work together to deliver them. When clinical operations and supply chain are fully aligned, demand signals, inventory positioning, and resupply execution can function as intended, reducing risk, minimizing waste, and ensuring continuity of treatment at the patient level.

About The Author:

Casey Witt is a clinical research and drug development leader with more than 15 years of experience, combining scientific depth with operational leadership for early-stage biotech companies. At Foxglove Clinical, she applies expertise in site relationship management, CRO oversight, and sponsor-side execution to help biotech teams advance programs into the clinic while maintaining quality and patient focus. Her background spans CNS, oncology, and rare disease programs across modalities including small molecules, radiopharmaceuticals, and gene therapies. She has led global Phase 2 and 3 adaptive trials and contributed to regulatory interactions, including FDA Advisory Committee engagement that supported returning a withdrawn drug to market. She is a co-author of peer-reviewed publications, a patent holder, and founded Foxglove Clinical to bring structure and strategy to clinical operations.